跳至主要内容
临床试验/NCT07677904
NCT07677904尚未招募不适用

Tuberculosis Clinical Registry in Europe - the TBnet Registry

Research Center Borstel2 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
2
主要终点
Extrapulmonary TB: Favourable treatment outcome

研究概览

简要总结

The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Its purpose is to centralize data on TB epidemiology, prevention, diagnosis, and treatment to improve care, support research, and ultimately help eliminate TB. The registry captures risk factors, diagnostic details (e.g., microbiology, imaging, drug resistance), treatment data, side effects, outcomes, and late complications.

详细描述

In Western Europe, however, tuberculosis is a rare disease, and individual clinics see only small numbers of patients. For clinical research on the epidemiology, prevention, diagnosis, and treatment of tuberculosis, it is therefore essential that patient data are collected and analyzed in a centralized manner. This allows for the adequate inclusion of at-risk groups and studying less common forms of tuberculosis (e.g., multidrug-resistant tuberculosis, extrapulmonary tuberculosis). Hence, the Tuberculosis Network European Trialsgroup TBnet e.V., aims to establish a tuberculosis registry in which long-term datasets from TB patients across Europe will be stored. The findings obtained from the tuberculosis registry will make an important contribution to combating and ultimately eliminating TB. TBnet is a pan-European clinical research network dedicated to improving the diagnosis, treatment, and prevention of tuberculosis and related mycobacterial diseases. Founded in 2006, TBnet brings together clinicians, scientists, and public health experts from more than 30 countries. The network has established large collaborative cohorts and conducts multicenter clinical studies, registries, and consensus projects that have shaped international TB guidelines. The TBnet Steering Committee will serve as data access committee: Research questions/data inquiries will be submitted to the TBnet Steering Committee through a structured process on the TBnet website and are approved only after internal and external peer review (as outlined in the TBnet statutes).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Tuberculosis
  • Age ≥ 18 years
  • Capacity to provide informed consent
  • Written informed consent to participate in the study

排除标准

  • Lack of capacity to provide informed consent
  • Age < 18 years

结局指标

主要结局

Extrapulmonary TB: Favourable treatment outcome

时间窗: December 2040

Identification of parameters that predict/are significantly associated with favorable outcome in EPTB

Drug-resistant TB: Description of treatment outcome

时间窗: December 2040

Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria

Drug-resistant TB: Description of treatment completion

时间窗: December 2040

Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events

Drug-susceptible TB: Mortality risk score

时间窗: December 2040

Development of a TB mortality risk score, defined by a final set of predictors and a weighted scoring system based on routine clinical, radiological, microbiological, and laboratory data.

Therapeutic drug monitoring: Description of Pharmacokinetics

时间窗: December 2040

Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed

次要结局

未报告次要终点

研究者

发起方
Research Center Borstel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anca Vasiliu

Anca Vasiliu MD PhD

Research Center Borstel

研究点 (2)

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